title: Intramuscular neridronate in postmenopausal women with low bone mineral density.
abstract: Compliance to osteoporosis treatment with oral bisphosphonates is very poor. Intermittent intravenous bisphosphonate is a useful alternative, but this route is not readily available. Neridronate, a nitrogen-containing bisphosphonate that can be given intramuscularly (IM), was tested in a phase 2 clinical trial in 188 postmenopausal osteoporotic women randomized to IM treatment with 25 mg neridronate every 2 weeks, neridronate 12.5 or 25 mg every 4 weeks, or placebo. All patients received calcium and vitamin D supplements. The patients were treated over 12 months with 2-year posttreatment follow-up. After 12-month treatment, all three doses were associated with significant bone mineral density (BMD) increases at both the total hip and spine. A significant dose-response relationship over the three doses was observed for the BMD changes at the total hip but not at the spine. Bone alkaline phosphatase decreased significantly by 40-55% in neridronate-treated patients, with an insignificant dose-response relationship. Serum type I collagen C-telopeptide decreased by 58-79%, with a significant dose-response relationship (P < 0.05). Two years after treatment discontinuation, BMD declined by 1-2% in each dose group, with values still significantly higher than baseline at both the spine and the total hip. Bone turnover markers progressively increased after treatment discontinuation, and on the second year of follow-up the values were significantly higher than pretreatment baseline. The results of this study indicate that IM neridronate might be of value for patients intolerant to oral bisphosphonates and unwilling or unable to undergo intravenous infusion of bisphosphonates.
authors.affiliation: Rheumatology Unit, Ospedale di Valeggio, University of Verona, 37067, Valeggio, Verona, Italy. silvano.adami@univr.it
authors.forename: Silvano
authors.initials: S
authors.lastname: Adami
authors.forename: Davide
authors.initials: D
authors.lastname: Gatti
authors.forename: Francesco
authors.initials: F
authors.lastname: Bertoldo
authors.forename: Leonardo
authors.initials: L
authors.lastname: Sartori
authors.forename: Ombretta
authors.initials: O
authors.lastname: Di Munno
authors.forename: Paolo
authors.initials: P
authors.lastname: Filipponi
authors.forename: Claudio
authors.initials: C
authors.lastname: Marcocci
authors.forename: Bruno
authors.initials: B
authors.lastname: Frediani
authors.forename: Ernesto
authors.initials: E
authors.lastname: Palummeri
authors.forename: Carmelo Erio
authors.initials: CE
authors.lastname: Fiore
authors.forename: Daniele
authors.initials: D
authors.lastname: Costi
authors.forename: Maurizio
authors.initials: M
authors.lastname: Rossini
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015519:Bone Density / Q000187:drug effects* / Q000502:physiology; D002118:Calcium / Q000008:administration & dosage / Q000627:therapeutic use*; D004164:Diphosphonates / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D008593:Menopause / Q000502:physiology; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy*; D014807:Vitamin D / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D004164:Diphosphonates; D014807:Vitamin D; C053389:6-amino-1-hydroxyhexane-1,1-diphosphonate; D002118:Calcium